The epidemic of acquired immunodeficiency syndrome (AIDS) has led health care workers to focus on the risk they face in the hospital and clinic environments. In the United States, nearly 150,000 cases of AIDS in adults and adolescents were reported through July 1990.
In addition to AIDS, hospital workers have reason to be concerned about other illnesses they may be exposed to in the workplace. The Hepatitis Branch of the Centers for Disease Control has estimated that hundreds of health care workers die each year from the direct or indirect consequences of occupationally acquired hepatitis B. Additionally, thousands more become infected with the virus. Other studies have documented the transmission of at least 20 different pathogens by "needlestick" injuries. Needlestick injuries can occur, for example, in the process of collecting and/or transferring bodily fluids.
Despite the presumed widespread knowledge of the potential dangers of needlesticks, the incidence of these injuries is increasing. Furthermore, although the number of incidents of transmission of the HIV virus after a needlestick is relatively low (currently estimated to be less than 4/1000 needlesticks, infections in health care workers have been attributed to needlestick exposures. Not only are the medical consequences of needlesticks worrisome, the psychological consequences of unnecessary needlesticks are ever present for health care workers and their spouses or sexual partners.
Needlestick injuries effect all hospital personnel and occur throughout hospitals. Virtually every type of hospital personnel has sustained a needlestick injury at one time or another. This includes nurses, doctors, technicians, and housekeeping personnel. In addition, virtually every ward and department has been the site of needlesticks. Of further concern is the fact that in one study only 54% of those personnel who were victims of needlesticks reported the incident. In a large majority of cases, accidental needlesticks occurred during blood drawing procedures. In view of the foregoing, it is readily apparent that the risk of needlestick injuries and the concomitant transfer of potentially life threatening pathogens is a constant threat to hospital and clinical personnel.
Attempts have been made to address this problem, especially in the area of transferring bodily fluids from a syringe to a test tube. One such device is disclosed in U.S. Pat. No. 4,840,618 issued to Marvel. The Medical Safety Device disclosed in Marvel comprises a round elongated handle sized for being held in the fisted grip of a person. This handle loosely receives a test tube. A shield is positioned on top of the handle and extends radially outwardly therefrom to an extent sufficient to substantially shield the fisted hand of the person gripping the handle. It is further disclosed that there is an opening in the side of the handle to permit the test tube to be contacted to facilitate its ejection from the cavity in the handle, and to permit the test tube to be held in place while a syringe needle is extracted from the test tube to prevent slippage of the tube from the handle. A small opening in the end of the handle prevents a vacuum from forming between the bottom of the test tube and the bottom of the test tube cavity in the handle.
While Marvel provides a certain degree of safety with the shield, additional drawbacks exist. The need to hold the test tube through the opening in the handle can lead to further problems. For example, in the event the user's hand slips, it is possible that a tube could be pulled out of the holder while attempting to extract a needle. This could lead to breakage of the tube and/or spillage of the fluid. Additionally, if too much pressure is asserted on the side of the wall by the user, it is possible that the tube will break causing cuts and a possible transfer of pathogens to the holder of the tube. Also, if any blood is on the outside of the tube undesirable contact can occur. Moreover, this structure necessitates that the user's hand (other than the hand holding the needle) be in the vicinity of the needle which is dangerous even with the shield present. This is obviously undesirable.
Additionally, this structure only enables a single tube to be held. In certain instances, it is necessary or desirable to transfer fluids into or from a plurality of tubes.
A structure similar to Marvel is also disclosed in U.S. Pat. No. 4,742,910 issued to Staebler.
In U.S. Pat. 4,982,850 issued to Mears there is shown another hand held test tube holder structure. This device includes a base 12 which is designed to allow the test tube holder to stand independently on "balancing pads 26, 28 and 30. These balancing pads are undesirable since they permit a holder to slide along a surface or allow the holder to be easily knocked over. These are considered undesired movements. Each of the shafts 14-22 which hold the tubes, has a corresponding frontal slot 32-40, respectively. It is specifically disclosed that the shafts have a series of holes 42-50 aligned therewith to enable the test tubes or vials to be loosely inserted into the holder. This is undesirable since a tube can easily slide out of the holder.
It is disclosed that, in use, the user typically receives one or more vials that are already filled with blood samples that may be infected with the AIDS virus, and inserts the vials into the vertical shafts. There, they are stored until the user desires to transfer a fluid sample. After choosing the vial from which or to which a sample is to be transferred, the user places him thumb through the corresponding slot and presses the vial against the back of the corresponding shaft. A sample is removed from that vial by tilting the holder and needle toward one another and inserting the needle into the vial's top. This test tube holder is similar to Marvel in that it provides a safety shield at the top, it is hand held and the user contacts the tubes through a hole in the shaft to hold them in place. In at least one respect it differs from Marvel since it is designed for holding a plurality of tubes.
Therefore, this invention also suffers from many of the drawbacks of Marvel's device since the user must contact the vial to hold it in place while a needle is being withdrawn and further, because it requires a user's hand to contact the tubes and be near the needle, it must be tilted towards the needle and the tubes fit loosely into the vertical shafts.
Of course, various types of test tube racks and holders in general are known in the prior art, but to the knowledge of the applicant, none have been designed in order to facilitate and improve the safety of fluid transfer or address the other objects of the present invention.